Lupin bags USFDA nod for Travoprost Ophthalmic Solution
Mumbai: Global pharma major Lupin Limited has announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Travoprost Ophthalmic Solution USP, 0.004%(Ionic Buffered Solution), to market a generic equivalent to the reference listed drug (RLD)Travatan Z Ophthalmic Solution, 0.004%, of Sandoz Inc.
The product will be manufactured at Lupin’s Pithampur facility in India.
Travoprost Ophthalmic Solution USP, 0.004%, is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.
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Medical Dialogues team had earlier reported that the Company had received approval from the U.S. FDA for its Abbreviated New Drug Application for Loteprednol Etabonate Ophthalmic Suspension, 0.5%, to market a generic equivalent to the reference listed drug (RLD)Lotemax Ophthalmic Suspension, 0.5%, of Bausch & Lomb Inc.
Read also: Lupin bags USFDA approval for Loteprednol Etabonate Ophthalmic Suspension
Global pharma major Lupin Limited has announced that the Company has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Loteprednol Etabonate Ophthalmic Suspension, 0.5%, to market a generic equivalent to the reference listed drug (RLD)Lotemax Ophthalmic Suspension, 0.5%, of Bausch & Lomb Inc.
Travoprost Ophthalmic Solution USP, 0.004% (RLD Travatan Z), had estimated annual sales of USD 77 million in the U.S. (IQVIA MAT March 2024).
Read also: Lupin bags USFDA approval for Loteprednol Etabonate Ophthalmic Suspension
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. The company invested 7.8% of its revenue in research and development in FY24.
Lupin has 15 manufacturing sites, 7 research centers.
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